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MULTIPLE INGREDIENT JOINT HEALTH PRODUCTS

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) for natural health product (NHP) market authorization of multiple ingredient joint health products that contain any two or more of the medicinal ingredients listed in Table 1. It is not intended to be a comprehensive review of the medicinal ingredients.
For products containing a single medicinal ingredient only, refer to the appropriate single ingredient monograph.

Notes

Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 5, 2012

Proper name(s), Common name(s), and Source material(s)

Table 1 Proper and common names and source materials of joint health ingredients
Proper name^{Table 1 Footnote 1}	Common name^{Table 1 Footnote 2}	Source material^{Table 1 Footnote 3}
Table 1 Footnotes Table 1 Footnote 1 At least one of the following references was consulted per proper name: ChemIDPlus 2012; Martindale 2012; Merck 2012; Ph.Eur. 2012; USP 35; USDA 2011; Kralovec and Barrow 2008; Towheed and Anastassiades 2007. Return to Table 1 footnote 1 referrer Table 1 Footnote 2 At least one of the following references was consulted per common name: BP 2012; ChemIDPlus 2012; Martindale 2012; Merck 2012; Ph.Eur. 2012; USP 35; Kralovec and Barrow 2008; Towheed and Anastassiades 2007; McGuffin et al. 2000. Return to Table 1 footnote 2 referrer Table 1 Footnote 3 At least one of the following references was consulted per source material: Martindale 2012; Merck 2012; Ph.Eur. 2012; USP 35; ITIS 2011; Froese and Pauly. 2008; Kralovec and Barrow 2008; NIH 2008;Dahiya et al 2006; ESCOP 2003; Blumenthal et al. 2000; BHC 1992. Return to Table 1 footnote 3 referrer Table 1 Footnote 4 Cartilage must be derived from healthy and domestic animals used for food by humans (USP 35). Return to Table 1 footnote 4 referrer Table 1 Footnote 5 Return to Table 1 footnote 5 referrer Corresponds to oil from the body of one or more of the following species in its natural triglyceride/triacylglycerol form and/or its concentrated esterified form: Anchovy (any species of Engraulidae) Jack or pompano (any species of Carangidae) Herring, shad, sardine or menhaden (any species of Clupeidae) Smelt (any species of Osmeridae) Mackerel, tuna, or bonito (any species of Scombridae) Sand lance (any species of Ammodytidae) Salmonids (any species of Salmonidae) Table 1 Footnote 6 The specific organisms used as source material(s) must be indicated in the Animal Tissue Form (ATF); simply indicating "crustaceans" is insufficient. Return to Table 1 footnote 6 referrer Table 1 Footnote 7 Acceptable salts include potassium chloride and sodium chloride (Kralovec and Barrow 2008). Example of labelling: glucosamine sulfate potassium chloride from shrimp. Return to Table 1 footnote 7 referrer Table 1 Footnote 8 References: Sitanggang et al. 2012; Kralovec and Barrow 2008; Chmielowski et al. 2007; Dahiya et al 2006. Return to Table 1 footnote 8 referrer
Chondroitin sulfate	Chondroitin sulfate	Chondroitin sulfate sodium obtained from one or more of the following: Bovine (Bovidae) cartilage ^{Table 1 Footnote 4} Porcine (Suidae) cartilage ^{Table 1 Footnote 4} Avian (Phasianidae) cartilage ^{Table 1 Footnote 4}
Harpagophytum procumbens (Burch.) DC. ex Meisn. (Pedaliaceae)	Devil's claw	Secondary root tuber
Fish oil	Fish oil	Engraulidae - whole^{Table 1 Footnote 5} Carangidae - whole^{Table 1 Footnote 5} Clupeidae - whole^{Table 1 Footnote 5} Osmeridae - whole^{Table 1 Footnote 5} Scrombridae - whole^{Table 1 Footnote 5} Ammodytidae - whole^{Table 1 Footnote 5} Salmonidae - whole^{Table 1 Footnote 5}
glucosamine hydrochloride	glucosamine hydrochloride	Shrimp (Penaeidae) - exoskeleton^{Table 1 Footnote 6} Krill (Euphausiidae) - exoskeleton^{Table 1 Footnote 6} Prawn (Penaeoidea and/or Sergestoidea) - exoskeleton^{Table 1 Footnote 6} Crab (Cancridae) - exoskeleton^{Table 1 Footnote 6} Lobster (Nephropidae) - exoskeleton^{Table 1 Footnote 6} Aspergillus sp. (Trichocomaceae) - fermented^{Table 1 Footnote 8} Monascus sp. (Elaphomycetaceae) - fermented^{Table 1 Footnote 8} Rhizopus sp. (Mucoraceae) - fermented^{Table 1 Footnote 8}
glucosamine sulfate	glucosamine sulfate	Glucosamine sulfate potassium chloride and/or glucosamine sulfate sodium chloride from one or more of the following: Shrimp (Penaeidae) -exoskeleton ^{Table 1 Footnote 6} ^{Table 1 Footnote 7} Krill (Euphausiidae) - exoskeleton ^{Table 1 Footnote 6} ^{Table 1 Footnote 7} Prawn (Penaeoidea and/or Sergestoidea) - exoskeleton ^{Table 1 Footnote 6} ^{Table 1 Footnote 7} Crab (Cancridae) - exoskeleton ^{Table 1 Footnote 6} ^{Table 1 Footnote 7} Lobster (Nephropidae) - exoskeleton ^{Table 1 Footnote 6} ^{Table 1 Footnote 7}
methylsulfonylmethane; dimethyl sulfone; sulfonylbismethane	methylsulfonylmethane (MSM)	methylsulfonylmethane (MSM)

Route(s) of administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Notes

It is mandatory for all products to cite at least one use or purpose statement from Table 2.
A use or purpose statement is acceptable only if at least one medicinal ingredient associated with that statement is present at a dose at or above the minimum daily dose listed in Table 2.
Medicinal ingredients which do not meet the minimum daily dose for a use or purpose statement will be considered as acceptable complementary medicinal ingredients in product formulations.

Table 2 Joint health use or purpose statements and associated daily doses
Medicinal ingredient	Use or purpose^{Table 2 Footnote 11}	Daily dose
Medicinal ingredient	Use or purpose^{Table 2 Footnote 11}	Minimum ^{Table 2 Footnote 22}	Maximum ^{Table 2 Footnote 3}
Table 2 Footnotes 1 Table 2 Footnote 1 At least two of the following references were consulted per use or purpose: Herrero-Beaumont et al. 2007; Mazières et al. 2007; Towheed and Anastassiades 2007; Kim et al. 2006; Mills and Bone 2005; Uebelhart et al. 2004; Usha and Naidu 2004; Braham et al. 2003; ESCOP 2003; Hoffmann 2003; Pavelka et al. 2002; Mazières et al. 2001; Reginster et al. 2001; Thie et al. 2001; Volker et al. 2000; Houpt et al. 1999; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998; Sköldstam et al. 1992. Return Table 2 to footnote 1 referrer Table 2 Footnote 2 At least one of the following references was consulted per minimum dose: Herrero-Beaumont et al. 2007; Mezieres et al. 2007; Fitzpatrick 2005; Mills and Bone 2005; Uebelhart et al. 2004; Usha and Naidu 2004; Hoffmann 2003; Pavelka et al. 2002; Reginster et al. 2001; Mezieres et al. 2001; Volker et al. 2000; Houpt et al. 1999; Bucsi and Poor 1998; Uebelhart et al. 1998 Return Table 2 to footnote 2 referrer Table 2 Footnote 3 At least one of the following references was consulted per maximum dose: Herrero-Beaumont et al. 2007; Hathcock and Shao 2006; Kim et al. 2006; Braham et al. 2003; Pavelka et al. 2002; Reginster et al. 2001; Bourgeois et al. 1998; US FDA 1997; BHC 1992. Return Table 2 to footnote 3 referrer Table 2 Footnote 4 The EPA:DHA ratio for fish oil must be between 0.5 and 2:1 (Volker et al. 2000; Sköldstam et al. 1992) and potency must be expressed as the quantity (mg) and/or percent (%) of EPA and DHA (% w/w) relative to the total quantity of fish oil. Return Table 2 to footnote 4 referrer Table 2 Footnote 5 The daily dose for glucosamine hydrochloride in combination with glucosamine sulfate is subject to the following limitations: the sum of the percents of their individual maximum daily doses must not exceed 120%; the percent of an individual maximum daily dose cannot exceed 100% [e.g. a product providing a daily dose of 2,000 mg glucosamine hydrochloride (100% of the 2,000 mg maximum daily dose) + 300 mg glucosamine sulfate (20% of the 1,500 mg maximum daily dose) would be acceptable (100%+20%=120%)]. Return Table 2 to footnote 5 referrer Table 2 Footnote 6 Not to exceed 2,000 mg per dose (Kim et al. 2006) Return Table 2 to footnote 6 referrer
chondroitin sulfate	Helps to relieve joint pain associated with osteoarthritis. Helps to relieve pain associated with osteoarthritis of the knee.	800 mg	1,200 mg
Devil's claw	Used in Herbal Medicine to help relieve joint pain associated with osteoarthritis.	600 mg	7,500 mg
Fish oil^{Table 2 Footnote 4}	In conjunction with conventional therapy, helps to reduce the pain of rheumatoid arthritis in adults.	2,800 mg docosahexaenoic acid (DHA) + eicosapentaenoic acid (EPA)	3,000 mg DHA + EPA
glucosamine hydrochloride ^{Table 2 Footnote 5}	If one of the following statements is used, it must be verbatim: "A factor in maintaining healthy cartilage" "Helps to maintain healthy cartilage." "A factor in maintaining joint health" "Helps to maintain joint health."	1,500 mg	2,000 mg
glucosamine sulfate ^{Table 2 Footnote 5}	Helps to relieve joint pain associated with osteoarthritis. Helps to relieve pain associated with osteoarthritis of the knee. Helps to protect against the deterioration of cartilage. A factor in maintaining healthy cartilage and/or joint health	1,500 mg	1,500 mg
methysulfonylmethane (MSM) ^{Table 2 Footnote 6}	Helps to relieve joint pain associated with osteoarthritis. Helps to relieve the pain associated with osteoarthritis of the knee.	1,500 mg	6,000 mg

Dose(s)

Subpopulation(s)

Adults (≥ 19 years)

Quantity(ies)

Refer to Table 2.

Direction(s) for use

For products providing ≥ 1,500 mg, per day methylsulfonylmethane (MSM):
Take with food. Avoid taking at bedtime (Kim et al. 2006).

For all other products, the following statement is optional:
Take with food.

Duration of use

Notes

A duration of use statement is required for all products citing use or purpose statements associated with Chondroitin sulfate, Devil's claw, Glucosamine (hydrochloride and sulfate) or MSM.
If more than one duration of use statement is indicated for a particular product formulation, only the shortest applicable duration of use statement is required on the PLA and product label. For example, a product citing use or purpose statements for Chondroitin sulfate and Glucosamine hydrochloride need only include the following duration of use statement on the product label: "Use for a minimum of 1 month to see beneficial effects."

Table 3 Duration of use
Medicinal ingredient(s)	Duration of use^{Footnote 1}
Table 3 Footnotes Table 3 Footnote 1 At least one of the following references was consulted per duration of use statement: Bjordal et al. 2007; Mehta et al. 2007; Kim et al. 2006; Usha and Naidu 2004; ESCOP 2003; Houpt et al. 1999; Qiu et al. 1998. Return to Table 3 footnote 1 referrer
chondroitin sulfate	Use for a minimum of 3 months to see beneficial effects.
Devil's claw	Use for a minimum of 2-3 months to see beneficial effects.
glucosamine hydrochloride	Use for a minimum of 1 month to see beneficial effects.
glucosamine sulfate
methylsulfonylmethane (MSM)

Risk Information

Statement(s) to the effect of:

Caution(s) and warning(s)

For all products:

If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
If symptoms worsen, consult a health care practitioner.

Contraindication(s)

No statement required.

Known advers reaction(s)

For products containing MSM: Some people may experience mild gastrointestinal bloating, constipation or indigestion (Kim et al. 2006).

Storage conditions

For all products:
Store in airtight container, protected from light (Ph.Eur. 2012; USP 35).

For all products containing fish oil, except those encapsulated:
Refrigerate after opening (Wille and Gonus 1989).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPD) and must meet the limitations outlined in that database.

Specifications

The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
The following medicinal ingredients may comply with the specifications outlined in their respective pharmacopoeial monographs listed in Table 4 below: Devil's claw, Fish oil, Glucosamine (hydrochloride and/or sulfate) and MSM.
In order to minimize the risk of Transmissible Spongiform Encephalopathies (TSEs) from products sourced from bovine tissues, product licence applicants must have a veterinary certificate on file and must ensure that the following criteria has been met (Ph. Eur. 2008):
1. Source animal is fit for human consumption;
2. Source material can be traced back to the herd or animal;
3. Avoidance of cross-contamination with high-infectivity tissues is ensured during sourcing;
4. Manufacturing procedures that are known to reduce infectivity are implemented (e.g. procedures that are in accordance with those outlined in Chapter 5.02.08 of the European Pharmacopoeia 2012 'Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products').
Peroxide, anisidine, and totox values of fish oil and omega-3 fatty acids derived from fish oil must be in accordance with the methods set out by the Association of Analytical Community (AOAC) and/or Pharmacopoeial analytical methods. These specifications are necessary to ensure the oxidative stability of the fish oil and the omega-3 fatty acids derived from fish oil (HC 2007). Refer to Table 5 below.
The dioxins, polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs); thedioxin-like polychlorinated biphenyls (DL PCBs; and the polychlorinated biphenyls (PCBs) are contaminants in oils from marine sources. Testing for these contaminants are required and must be performed using either the analytical method of the European Commission Regulation EU 252/2012 (EU 2012) or the U.S. Environmental Protection Agency’s method 1613B for PCDDs and PCDFs and method 1668A for PCBs (USP 35; US EPA 2010, 2008,1994). Applicants are advised to consult the Council of the European Union document on these contaminants for further information (EU 2011). Refer to Table 6 below.

Table 4 Monographs published in the British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) and U.S. Pharmacopeia(USP)
Medicinal ingredient	Pharmacopeia	Monograph
chondroitin sulfate	BP	Chondroitin Sulfate Sodium
	Ph. Eur.	Chondroitin Sulfate Sodium
	USP	Chondroitin Sulfate Sodium Tablets
Devil's claw	BP	Devil's Claw Root
Devil's claw	Ph. Eur.	Devil's Claw Root
Fish oil	BP	Fish Oil, Rich in Omega-3-Acids Farmed Salmon Oil
	Ph. Eur.	Fish oil rich in omega-3 acids Salmon oil, Farmed
	USP	Fish Oil Containing Omega-3 Acids
glucosamine hydrochloride	Ph. Eur.	Glucosamine Hydrochloride
glucosamine hydrochloride	USP	Glucosamine Hydrochloride
glucosamine sulfate	Ph. Eur.	Glucosamine Sulfate Sodium Chloride
glucosamine sulfate	USP	Glucosamine Sulfate Potassium Chloride Glucosamine Sulfate Sodium Chloride
methylsulfonylmethane (MSM)	USP	Methylsulfonylmethane

Table 5 Maximum values of oxidative stability parameters for fish oil (HC 2007)
Oxidative stability parameter	Maximum value
Peroxide value (PV)	5 mEq/kg
p-Anisidine value (AV)	20
Totox value	26 (calculated as (2 x PV) + AV)

Table 6 Maximum levels of dioxins, dioxin-like polychlorinated biphenyls (DL PCB) and polychlorinated biphenyls (PCB) in oils from marine sources
Dioxin, DL PCB, and PCB contaminants	Maximum level
Dioxin, DL PCB, and PCB contaminants	EU 1259/2011	USP 35
Table 6 Footnotes Table 6 Footnote 1 Expressed in World Health Organization (WHO) toxic equivalents using WHO-toxic equivalent factors (TEFs). Analytical results relating to 17 individual dioxin congeners of toxicological concern are expressed in a single quantifiable unit: 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) toxic equivalent concentration (TEQ) (USP 35; EU 2011). Return to Table 6 footnote 1 referrer Table 6 Footnote 2 Sum of dioxins: WHO-PCDD/F-TEQ (USP 35; EU 2011) Return to Table 6 footnote 2 referrer Table 6 Footnote 3 Sum of dioxins and dioxin-like PCBs: WHO-PCDD/F-PCB-TEQ (EU 2011) Return to Table 6 footnote 3 referrer Table 6 Footnote 4 Sum of PCB congeners 28, 52, 101, 118, 138, 153 and 180 (USP 35; EU 2011) Return to Table 6 footnote 4 referrer Table 6 Footnote 5 Equivalence: 0.5 ppm = 500 ng/g Return to Table 6 footnote 5 referrer
Dioxins (sum of PCDDs + PCDFs) ^{Table 6 Footnote 1} ^{Table 6 Footnote 2}	1.75 pg/g	1.0 pg/g
Sum of dioxins and DL PCBs ^{Table 6 Footnote 1} ^{Table 6 Footnote 3}	6 pg/g
PCBs ^{Table 6 Footnote 4}	200 ng/g	0.5 ppm ^{Table 6 Footnote 5}

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MULTIPLE INGREDIENT JOINT HEALTH PRODUCTS

Date

Proper name(s), Common name(s), and Source material(s)

Table 1 Footnotes

Route(s) of administration

Dosage form(s)

Use(s) or Purpose(s)

Table 2 Footnotes 1

Dose(s)

Duration of use

Table 3 Footnotes

Risk Information

Caution(s) and warning(s)

Contraindication(s)

Known advers reaction(s)

Storage conditions

Non-medicinal ingredients

Specifications

Table 6 Footnotes

References cited

References reviewed